Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00041171
First received: July 8, 2002
Last updated: January 11, 2007
Last verified: December 2006
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. St. John's wort may interfere with the effectiveness of chemotherapy. It is not yet known if chemotherapy is more effective with or without St. John's Wort in treating solid tumors.

PURPOSE: Randomized phase III trial to compare the effectiveness of docetaxel with or without St. John's wort in treating patients who have solid tumors that cannot be removed by surgery.


Condition Intervention Phase
Adult Solid Tumor
Breast Cancer
Head and Neck Cancer
Kidney and Urinary Cancer
Male Reproductive Cancer
Thorax and Respiratory Cancer
Drug: Hypericum perforatum
Drug: docetaxel
Procedure: cancer prevention intervention
Procedure: chemotherapy
Procedure: complementary and alternative therapy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Hypericum Perforatum (St. John's Wort) Combined With Docetaxel in Patients With Unresectable Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

OBJECTIVES:

  • Determine the effect of Hypericum perforatum (St. John's Wort) on the pharmacokinetic clearance of docetaxel in patients with unresectable solid tumors.
  • Determine the effect of Hypericum perforatum on the production and plasma concentrations of M4-C13-hydroxydocetaxel in these patients.
  • Determine the effects of this drug on the pharmacodynamics of docetaxel in these patients.
  • Determine the relationship between the effects of this drug on docetaxel metabolic clearance and CYP3A4/CYP3A5 genotype in these patients.
  • Determine the relationship between the effect of this drug on docetaxel metabolic clearance and p-glycoprotein genotype in these patients.
  • Determine the relationship between the effect of this drug on docetaxel clearance and pregnane receptor genotype in these patients.
  • Assess compliance with this drug in these patients.
  • Assess the steady state concentrations of hyperforin, one of the putative psychoactive components of Hypericum perforatum, in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients who have not been receiving chronic Hypericum perforatum (St. John's Wort) are assigned to group A, while a cohort of 8 patients who have been receiving chronic Hypericum perforatum are assigned to group B.

  • Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive oral placebo three times daily on days 1-14 and docetaxel IV over 1 hour on day 15.
  • Arm II: Patients receive oral Hypericum perforatum three times daily on days 1-14 and docetaxel as in arm I.
  • Group B (non-randomized group): Patients receive docetaxel as in arm I and continue to receive their chronic regimen of Hypericum perforatum except on day 15.

Treatment in both groups repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for new primaries and survival only.

PROJECTED ACCRUAL: Approximately 92 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed unresectable solid tumor, including, but not limited to, the following:
  • Lung cancer
  • Breast cancer
  • Head and neck cancer
  • Bladder cancer
  • Prostate cancer
  • Must be suitable for treatment with single-agent docetaxel
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • CTC 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than upper limit of normal (ULN)
  • Alkaline phosphatase less than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN
  • BUN no greater than 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bone marrow transplantation
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No prior docetaxel
  • No more than 2 prior chemotherapy regimens
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal agents except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • At least 3 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery

Other:

  • At least 6 months since prior Hypericum perforatum (St. John's Wort)
  • At least 1 week since prior CYP3A enzyme inducers including:
  • Phenobarbital
  • Phenytoin
  • Carbamazepine
  • Lamotrigine
  • Rifampin
  • Rifabutin
  • Isoniazid
  • Sulfinpyrazone
  • Pioglitazone
  • Anti-HIV drugs such as efavirenz or nevirapine
  • At least 1 week since prior CYP3A enzyme inhibitors including:
  • Erythromycin
  • Clarithromycin
  • Azithromycin
  • Roxithromycin
  • Ketoconazole
  • Fluconazole
  • Itraconazole
  • Metronidazole
  • Chloramphenicol
  • Ritonavir
  • Saquinavir
  • Indinavir
  • Nelfinavir mesylate
  • Delavirdine
  • Amiodarone
  • Cyclosporine
  • Tacrolimus
  • Sirolimus
  • Nefazodone
  • Fluvoxamine
  • No concurrent CYP3A enzyme inducers
  • No concurrent CYP3A enzyme inhibitors
  • No ethanol (especially red wine), grape fruit juice, or seville orange juice (CYP3A enzyme inhibitor) within 3 days before or after receiving docetaxel
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041171

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Lionel D. Lewis, MD Norris Cotton Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00041171     History of Changes
Other Study ID Numbers: CDR0000069449, CLB-60002
Study First Received: July 8, 2002
Last Updated: January 11, 2007
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
recurrent non-small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
unspecified adult solid tumor, protocol specific
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage III squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
stage III verrucous carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV verrucous carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014